Long-Term Treatment with Single-Tablet Combination of Macitentan and Tadalafil in Pulmonary Arterial Hypertension: Results from A DUE and Its Open-Label Period - PubMed
5 hours ago
- #Clinical Trial
- #Pulmonary Arterial Hypertension
- #Macitentan-Tadalafil Combination
- A DUE study evaluated a fixed-dose combination (FDC) of macitentan 10 mg and tadalafil 40 mg (M/T FDC) for pulmonary arterial hypertension (PAH).
- M/T FDC significantly improved pulmonary vascular resistance at Week 16 compared to monotherapies.
- The open-label (OL) period provided long-term safety and efficacy data for M/T FDC over up to 2 years.
- 185 patients received M/T FDC for a median of 105.1 weeks, with 91% survival at the end of the study (EOS).
- Mean change in six-minute walk distance (6MWD) from baseline to OL Week 120 was 60.5 m (84.2).
- NT-proBNP levels decreased to 50.2% of baseline at OL Week 120.
- Adverse events (AEs) occurred in 94.1% of patients, with serious AEs in 33.5% and 10.3% discontinuing due to AEs.
- Seven on-treatment deaths occurred, all deemed unrelated to M/T FDC.
- Long-term M/T FDC treatment was well-tolerated with sustained efficacy in 6MWD and NT-proBNP over 2 years.
- The study supports the use of single-tablet combination therapy for simplifying PAH treatment.